ANTIBACTERIAL HAND WASH FOR KIDS PINEAPPLE AND COCONUT SCENTED- benzalkonium chloride gel 
Ganzhou Olivee Cosmetic Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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hand wash

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1500%

Purpose

Antibacterial

USE

Helps eliminate bacteria on hands

Warnings

For external use only.

When using this product

avoid contact with eyes; in case of contact, flush eyes with water.

Stop use and ask a doctor if

  • irritation and redness develops and persists.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply onto wet hands working into a lather. Rinse thoroughly.

Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Hydroxethylcellulose, Fragrance (Parfum), Phenoxyethanol, Bezyl Alcohol, Glycerin, Citric Acid, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract.

package

label image

ANTIBACTERIAL HAND WASH FOR KIDS PINEAPPLE AND COCONUT SCENTED 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ACETYLTRIETHYL CITRATE (UNII: 5WBR36T90E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56136-083-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/21/2020
Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
Establishment
NameAddressID/FEIBusiness Operations
Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-083)

Revised: 7/2020
Document Id: c06389fe-2274-430d-97be-ab4290dd8670
Set id: a906e751-6645-467d-8238-151d15a0b8fb
Version: 1
Effective Time: 20200721
 
Ganzhou Olivee Cosmetic Co., Ltd.